FDA 510(k) Application Details - K980482

Device Classification Name

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510(K) Number K980482
Device Name TRIANGLE SLING
Applicant INFLUENCE, INC.
11812 QUINCE MILL DR.
NORTH POTOMAC, MD 20878 US
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Contact MARK D KRAMER
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Regulation Number

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Classification Product Code OTN
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Date Received 02/09/1998
Decision Date 03/27/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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